User experience of a combined 2-in-1 home ECG and blood pressure monitor: a qualitative study

We evaluated the usability of a novel 2-in-1 blood pressure (BP) and electrocardiogram (ECG) monitor (developed to facilitate earlier detection of hypertension and atrial fibrillation). Arrhythmia clinic patients and public volunteers were recruited. Key themes were generated from semi-structured interviews.

Patients (n=12) found the experience of measuring ECG and BP equally positive. Public volunteers (n=11) found BP measurement a more positive experience compared with ECG recording. Several key themes were generated: patient empowerment, investment in health, technical know-how, user requirements and ergonomics.

In conclusion, the 2-in-1 BP and ECG monitor received overall positive reviews, showcasing the device’s potential to enhance patient care in the management of hypertension and atrial fibrillation.

Introduction

Hypertension affects ~1 billion people worldwide and is highly prevalent in adults with atrial fibrillation (AF), especially those >60 years old.¹ The combination of AF and hypertension has a 1.8–2-fold increased stroke risk compared with those without hypertension.² Stroke prevention is a key goal in AF and stroke management, and early AF detection and good blood pressure (BP) control are vital care components.^3–4

Image source: OMRON website

Devices recording home BP are commonplace, but the development of a 2-in-1 home electrocardiogram (ECG)/BP monitor is novel. The OMRON Complete is a 2-in-1 single-lead ECG/BP monitor developed by Omron Healthcare (Kyoto, Japan) with the ECG software and technology powered by AliveCor (Mountain View, CA, USA).⁵ It requires a smartphone to facilitate the use of the OMRON phone application (OMRON connect) for data display/sharing/record-keeping; it allows data-interpretation with a clinically validated algorithm for AF/tachycardia/bradycardia/sinus rhythm detection (with CE [conformité Européenne] mark and FDA [Food and Drug Administration] approval in terms of regulatory clearance).^6–7 The sensitivity and specificity for the detection of AF are 97% and 96%, respectively.⁸ The OMRON Complete BP monitor is also approved by the British and Irish Hypertension Society (BIHS).⁹ An image illustrating the use of this device is shown in figure 1.

Overall, this novel device may facilitate earlier detection of both AF and hypertension; however, its usability is poorly studied. Our study aimed to evaluate its use in patients and public volunteers.

Materials and method

We recruited two groups of participants:

• Consecutive patients attending our arrhythmia clinic at University Hospitals Coventry and Warwickshire NHS Trust (UHCW), Coventry.
• Public volunteers (part of the UHCW public participation group).

After providing informed consent and receiving instructions on how to use the device, patients were asked to use it twice daily over a two- to four-week period. Public volunteers were invited to an interactive workshop to explore and test the device.

Qualitative research methods were used to explore ease of use, impact on lifestyle, device-specific issues, potential adaptions/improvements, and satisfaction using a semi-structured interview in-person or by phone for the patient group, or via follow-up focus groups for the public volunteers. All interviews were audio recorded, transcribed verbatim and coded. Iterative thematic analysis was used to analyse the data using the six-step framework developed by Braun and Clarke.¹⁰ A second coder independently reviewed the codes and themes to ensure validity and reliability. The percentages presented in the results section equated to the proportion of codes categorised within the theme out of all the total codes obtained from the patient-coded data. For both groups, quantitative data were obtained via a questionnaire using a five-point Likert scale and t-test performed for intergroup comparisons. Approval was obtained from our UHCW research and development (R&D) department.

Results

Twenty patients were recruited from the arrhythmia clinic and 11 were public volunteers. Baseline demographics for both are shown in table 1. Out of the 20 clinic patients, eight did not respond to the questionnaire (five used the device and did not respond to the questionnaire, three withdrew from the usability study). The patient group had more known hypertensives and AF. In the patient group, 8% owned a home ECG-monitor and 67% owned a BP-monitor, and ECG and BP recordings were performed monthly. A similar percentage (9%) in the volunteer group owned a home ECG monitor, but the recording was more frequent (weekly). Although the majority (82%) in the volunteer group owned a BP monitor, the use was less frequent compared with the patient group.

Clinic patients found the experience of measuring both ECG and BP positive (based on similar scores), while public volunteers found BP measurement a more positive experience compared with ECG recordings. Both groups found interpreting BP results easier than interpreting ECG results, with the greatest differences in scores seen among public volunteers. Both groups felt they needed more support interpreting ECG tracings compared with BP metrics. Clinic patients were significantly more positive towards their experiences of taking both ECG/BP measurements concurrently, with 10 of 12 (83.3%) clinic patients and 7 of 11 (63.6%) public volunteers finding the device beneficial. The user-friendliness of the device did not differ significantly in terms of age (‘Easy–Very easy to use’ vs. ‘Neutral’ response, 62 ± 4 years vs. 54 ± 5 years, p=0.23).

Six key themes were generated from patient semi-structured interviews (figure 2):

1. Patient empowerment (17%): this was the main theme developed, as participants had the ability to actively monitor their own condition because they had access to technology that was usually limited to medical professionals. Many felt the device reduced their need for frequent follow-ups.
2. Investment in health (12%): patients showed a willingness to purchase/invest in devices that helped maintain/monitor their health.
3. Device requirements (15%): patients recognised a basic level of technological skill was required to see the true benefit of the device. A few participants raised concerns about potential difficulties using the device, due to manual dexterity in instances where patients may have arthritis, and in using the device in areas with poor internet connectivity. One patient could not be recruited, as they did not have a smartphone.
4. User requirements (18%): patients wanted a simple system, which they could trust and be integrated into existing clinical processes, supporting their clinical team.
5. Support need (26%): patients welcomed the ability to share their results with clinicians and were keen to learn more about ECGs. Additionally, the ability to observe/receive live feedback on their cardiac rhythm/BP was something patients found both convenient and reassuring.
6. Ergonomics (9%): patients liked the design of the device and familiarity of it due to already owning a BP machine.

Six key themes were generated from the public volunteer semi-structured interviews (figure 2):

1. Familiarity of home-monitoring devices (9%): the public felt that the device was familiar, as many owned a home BP monitor.
2. True value of device (8%): the public recognised there was a specific target population who would benefit from the device, particularly those who had heart conditions requiring monitoring.
3. User support (39%): like the patient group, many found the system simple to use and wanted to learn more about ECGs and how they could capture the best quality trace for the clinical team to review.
4. Technological requirements (20%): the public recognised users needed a smartphone and basic technological skills.
5. Inclusive and accessible device design (13%): the public liked the design of the device/easy interface; device size was handy for home use.
6. Factors influencing purchase (13%): many had seen OMRON devices used within their healthcare setting and thought the brand was reputable.

Discussion

This qualitative study explored the usability of a novel 2-in-1 home-monitoring device combining BP and ECG measurement, highlighting its acceptability and perceived value among patients and public volunteers. Overall, participants reported positive experiences using the device, with themes, such as patient empowerment, investment in health, and the need for healthcare/technical support and technological literacy, emerging as central to the user experience.

A key strength of this study lies in its dual-cohort design, capturing insights from both arrhythmia patients and members of the public. This allowed the exploration of perspectives from users with different baseline levels of engagement with health technology. Patients with AF or hypertension appreciated the ability to monitor both parameters at home, expressing a sense of empowerment and reassurance. Similarly, public volunteers recognised the potential utility of the device, particularly for individuals with underlying cardiovascular conditions, although some expressed lower confidence in interpreting the ECG results displayed on the device.

These findings align with the growing interest in home-based health-monitoring tools and digital-health platforms. With the increasing prevalence of AF and hypertension globally, there is a strong case for early detection strategies that are patient-led and accessible. Home ECG and BP monitors have the potential to reduce diagnostic delay and increase engagement with self-care, particularly when integrated with clinical workflows.

At present, only a limited number of commercially available devices offer both ECG and BP monitoring capabilities in a single unit. Apart from the OMRON Complete, the Withings BPM Core also provides dual functionality, with differences in the ECG recording methods and detection algorithms.¹¹ To date, there remains a paucity of published qualitative research examining user experience with alternative devices. Further head-to-head usability studies could provide insights into the relative strengths and limitations of different home-monitoring technologies in real-world use.

While the OMRON Complete uses a CE-marked and FDA-cleared algorithm for rhythm classification, its accuracy in detecting AF and other arrhythmias, especially in noisy or artefact-prone recordings, requires further scrutiny in routine clinical use. It is also worth noting that, although AF can be detected with this device, like all automated BP monitors, the BP measurement will be inaccurate in the presence of AF.

This study had several limitations. First, the small sample size and low survey response rate, particularly in the patient cohort, restrict the generalisability of findings. Non-response bias may have skewed perceptions toward more engaged or motivated participants. Second, this was a single-centre study involving a relatively tech-literate group, and individuals without access to smartphones or with limited digital literacy were underrepresented. Furthermore, there were challenges identified that were related to the device ergonomics (particularly for individuals with reduced manual dexterity) and poor internet connectivity, therefore, highlighting the need for more inclusive design considerations for future iterations of the device.

Future work should include larger, more diverse cohorts and explore the integration of such devices into clinical pathways. A comparison with alternative ECG/BP monitoring tools, as well as evaluation of the impact on clinical outcomes (e.g. earlier diagnosis, treatment initiation, patient-reported outcomes) and health economic analyses will also strengthen the evidence-base in this rapidly evolving field of digital cardiovascular health.

Conclusion

The 2-in-1 OMRON Complete ECG and BP monitor was well received by both patients and public volunteers, with users reporting improved confidence and engagement in managing their cardiovascular health. The device offers promising potential to support earlier detection and ongoing monitoring of AF and hypertension, especially when accompanied by appropriate user education and clinical support. While challenges related to usability and accessibility remain, this study lays the foundation for broader implementation studies that could inform policy and practice in digital cardiovascular care.

Key messages

• A novel 2-in-1 blood pressure and electrocardiogram (ECG) home-monitoring device has been developed to facilitate the earlier detection of hypertension and atrial fibrillation
• We designed a qualitative study to evaluate the usability of this home-monitoring device in two cohorts: clinic patients and public volunteers
• The 2-in-1 blood pressure and ECG recording device received positive reviews and highlighted its potential to enhance personalised patient care in the management of hypertension and atrial fibrillation

Conflicts of interest

None declared.

Funding

This feasibility study was funded by an Omron Healthcare grant.

Study approval

Approval was obtained from our UHCW NHS Trust research and development (R&D) department.

Acknowledgement

We would like to thank our R&D department for their assistance with this study.

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